Specific list for categorization of laboratory test systems, assays and examinations by complexity--PHS. Notice with comment period

The Clinical Laboratory Improvement Amendments of 1988, Public Law 100-578, requires that the Secretary provide for the categorization of specific laboratory test systems, assays and examinations by level of complexity. 42 CFR 493.17, published in the Federal Register on February 28, 1992 established criteria for such categorization. It is the Department's intention to complete the categorization of all currently available clinical laboratory test systems, assays and examinations prior to the effective date of 42 CFR 493 (September 1, 1992). This notice announces the third of a series of lists containing specific clinical laboratory test systems, assays and examinations, categorized by complexity. Additional lists of test systems, assays and examinations by complexity will be published periodically. A complete list of all laboratory test systems, assays and examinations, categorized by complexity, will be published in the form of a compilation of these Notices. Any clinical laboratory test system, assay or examination that is not on the compilation list will be considered high complexity, until categorized otherwise as provided under 42 CFR 493.17. After publication of the compilation list, categorization or recategorization of laboratory test systems, assays and examinations will follow the procedures delineated in 42 CFR 493.17(c). After the effective date of 42 CFR 493, notices will be published periodically in the Federal Register to announce any additional test system, assay or examination that has been categorized (or re-categorized) during the preceding interval.     

Specific list for categorization of laboratory test systems, assays and examinations by complexity--PHS. Notice with comment period

The Clinical Laboratory Improvement Amendments of 1988, Public Law 100-578, requires that the Secretary provide for the categorization of specific laboratory test systems, assays and examinations by level of complexity. 42 CFR 493.17, published in the Federal Register on February 28, 1992, established criteria for such categorization. It is the Department's intention to complete the categorization of all currently available clinical laboratory test systems, assays and examinations prior to the effective date of 42 CFR part 493. This notice announces the fourth of a series of lists containing specific clinical laboratory test systems, assays and examinations, categorized by complexity. This notice also includes deletions and corrections to the list of test systems, assays and examinations published on February 28, 1992. After publication and close of comment period on the published partial lists, a complete list of all laboratory test systems, assays and examinations, categorized by complexity, and responses to public comments received on the partial lists will be published in the form of a compilation of these Notices. Any clinical laboratory test system, assay or examination that is not on the compilation will be considered high complexity, until categorized otherwise as provided under 42 CFR 493.17. After publication of the compilation, applications will be taken to categorize (or re-categorize) other laboratory test systems, assays and examinations following the procedures delineated in 42 CFR 493.17(d). After the effective date of 42 CFR part 493, notices will be published periodically in the Federal Register to announce any additional test system, assay or examination that has been categorized (or re-categorized) during the preceding interval.     

Specific list for categorization of laboratory test systems, assays and examinations by complexity--PHS. Notice with comment period

The Clinical Laboratory Improvement Amendments of 1988, Public Law 100-578, requires that the Secretary provide for the categorization of specific laboratory test systems, assays and examinations by level of complexity. 42 CFR 493.17, published in the Federal Register on February 28, 1992 established criteria for such categorization. It is the Department's intention to complete the categorization of all currently available clinical laboratory test systems, assays and examinations prior to the effective date of 42 CFR 493 (September 1, 1992). This notice announces the second of a series of lists containing specific clinical laboratory test systems, assays and examinations, categorized by complexity. This notice also includes deletions and corrections to the list of test systems, assays and examinations published on February 28, 1992. Additional lists of test systems, assays and examinations as well as deletions and corrections will be published periodically. On or before September 1, 1992, a complete list of all laboratory test systems, assays and examinations, categorized by complexity, will be published in the form of a compilation of these Notices. Any clinical laboratory test system, assay or examination that is not on that final list will be considered high complexity, until categorized otherwise as provided under 42 CFR 493.17. After publication of the compilation, applications will be taken to categorize (or recategorize) other laboratory test systems, assays and examinations following the procedures delineated in 42 CFR 493.17(d). After September 1, 1992, notices will be published periodically in the Federal Register to announce any additional test system, assay or examination that has been categorized (or re-categorized) during the preceding interval.     

Notice of specific list for categorization of laboratory test systems, assays, and examinations by complexity--CDC. Notice with comment period

Regulations codified at 42 CFR 493.17, implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA), Public Law 100-578, require that the Secretary provide for the categorization of specific laboratory test systems, assays, and examinations by level of complexity. The criteria for such categorizations also are set forth in those regulations. This Notice announces the addition of approximately 1,300 test systems, assays, and examinations that have been categorized and notified between June 7, 1996 and December 31, 1996. These categorizations were effective on the issue date of the notification letter sent to the manufacturer and are subject to the 30 day comment period for this Notice.     

Medicare program; model fee schedule for physicians' services--HCFA. Notice with comment period

This notice announces and invites comments on a model fee schedule for physicians' services that is required by section 6102 of the Omnibus Budget Reconciliation Act of 1989. The model fee schedule provides very preliminary estimates for some, but not all, services to illustrate the effects of the Medicare physician payment fee schedule that will begin to take effect in January 1992. In accordance with section 6102(f)(11), we are making the model fee schedule available to the public through publication of this notice. Any comments received from the public will be considered carefully, but not specifically addressed in a subsequent proposed rule.     

Medicare program; criteria for Medicare coverage of lung transplants--HCFA. Notice with comment period

This notice announces a Medicare national coverage decision for lung and heart-lung transplantations. Lung transplantation refers to the transplantation of one or both lungs from a single cadaver donor. Heart-lung transplantation refers to the transplantation of one or both lungs and the heart from a single cadaver donor. We have determined that, under certain circumstances, lung transplants and heart-lung transplants are a medically reasonable and necessary service when furnished to patients with progressive end-stage pulmonary or cardiopulmonary disease and when furnished by Medicare participating facilities that meet specific criteria, including patient selection criteria. DATES: This notice is effective February 2, 1995. For information on how this notice effects Medicare payment for lung and heart-lung transplants, see sections E and F of this notice.     

CLIA program; categorization of tests and personnel modifications--HCFA. Final rule with comment period

In this rule we are responding to some of the comments on categorization of tests and personnel requirements received in response to rules published on February 28, 1992 and January 19, 1993. (In a future rule, we will be responding to the remaining comments.) We are revising our regulations to: Allow dentists and midlevel practitioners to perform tests in the "physician-performed" microscopy (PPM) subcategory of moderate complexity procedures (we now call the subcategory "provider-performed"); include three additional tests in PPM; and expand provisions relating to general supervisor and high complexity testing personnel.     

Medicare program; sustainable growth rate for fiscal year 1999--HCFA. Notice with comment period

This notice announces the fiscal year 1999 sustainable growth rate (SGR) for expenditures for physicians' services under the Medicare Supplementary Medical Insurance (Part B) program as required by section 1848(f) of the Social Security Act. The SGR for fiscal year 1999 is -0.3 percent. The negative fiscal year 1999 SGR is driven by the projected drop in Medicare fee-for-service enrollment.     

Medicare program; update of ambulatory surgical center payment rates--HCFA. Notice with comment period

This notice implements section 1833(i)(2)(A) of the Social Security Act, which requires that the payment rates for ambulatory surgical center (ASC) services be reviewed and updated annually, and responds to the public comments we received concerning the ASC payment rate update notice with comment published on December 31, 1991 (56 FR 67666), except for those concerning payment amounts for lithotripsy, which will be addressed in another Federal Register document. DATES: Effective date: The payment rates contained in this notice are effective for services furnished on or after October 1, 1992. Comments date: Comments will be considered if we receive them at the appropriate address, as provided below, by 5 p.m. on November 30, 1992.     

Medicare program; update of ambulatory surgical center payment rates and additions to and deletions from the current list of covered surgical procedures--HCFA. Notice with comment period

This notice implements section 1833(i)(2)(A) of the Social Security Act, which requires that the payment rates for ambulatory surgical center (ASC) services be reviewed and updated annually, and responds to the public comment we received concerning the ambulatory surgical center payment rate update notice with comment period published on July 5, 1990 (55 FR 27690). It also implements section 1833(i)(1) of the Social Security Act, which requires, in part, that the list of covered ambulatory surgical center procedures be reviewed and updated at least every 2 years. This notice announces additions to and deletions from the list of surgical procedures for which facility services are covered when the procedures are performed in an ASC. This notice also announces the assignment of payment groups for each procedure and responds to public comments received in response to the notice proposing additions to and deletions from the list of covered surgical procedures that was published on December 7, 1990.     

Medicare program; required laboratory procedures for rural health clinics--HCFA. Final rule with comment period

This rule revises the range of laboratory tests rural health clinics (RHCs) are required to provide in order to meet the Medicare conditions of participation. We are eliminating tests not classified as waived under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). RHCs that elect to furnish tests not waived under CLIA must comply with CLIA requirements as specified in regulations on Laboratory Requirements and will receive appropriate payment for covered laboratory services. We are making these changes because the CLIA program introduced participation requirements that may cause some RHCs to withdraw from the program, creating a shortage of available medical care in some areas.     

Medicare program; update of ratesetting methodology, payment rates, payment policies, and the list of covered procedures for ambulatory surgical centers effective October 1, 1998; extension of comment period--HCFA. Notice of extension of comment period for proposed rule

This notice extends the comment period for the third time on a proposed rule published in the Federal Register on June 12, 1998, (63 FR 32290). In that rule we proposed to make various changes, including changes to the ambulatory surgical center (ASC) payment methodology and the list of Medicare covered procedures. The comment period is extended for 60 days.     

Medicare program; update of ratesetting methodology, payment rates, payment policies, and the list of covered procedures for ambulatory surgical centers effective October 1, 1998; extension of comment period--HCFA. Notice of extension of comment period for proposed rule

This notice extends the comment period for a proposed rule published in the Federal Register on June 12, 1998 (63 FR 32290). In that rule we proposed to: Update the criteria for determining which surgical procedures can be appropriately and safely performed in an ambulatory surgical center (ASC): Make additions to and deletions from the current list of Medicare covered ASC procedures based on the revised criteria; Rebase the ASC payment rates using cost, charge, and utilization data collected by a 1994 survey of ASCs; Refine the ratesetting methodology that was implemented by a final notice published on February 8, 1990 in the Federal Register; Require that ASC payment, coverage, and wage index updates be implemented annually on January 1 rather than having these updates occur randomly throughout the year; Reduce requlatory burden; and Make several technical policy changes. This proposed rule implements requirements of section 1833(i) (1) and (2) of the Social Security Act. The comment period is extended for 30 days.     

Medicare, Medicaid, and CLIA programs; clinical laboratory requirements--extension of certain effective dates for clinical laboratory requirements under CLIA--CDC, HCFA. Final rule with comment period

This final rule extends certain effective dates for clinical laboratory requirements in regulations published on February 28, 1992, and subsequently revised December 6, 1994, that implemented provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This rule extends the phase-in date of the quality control requirements applicable to moderate and high complexity tests and extends the date by which an individual with a doctoral degree must possess board certification to qualify as a director of a laboratory that performs high complexity testing. These effective dates are extended to allow the Department additional time to issue revised quality control requirements and to ensure laboratory directors are able to complete certification requirements. These effective date extensions do not reduce the current requirements for quality test performance.     

Medicare program; update of ambulatory surgical center payment rates effective July 1, 1990--HCFA. Notice with comment period

This notice implements section 1833(i)(2(A) of the Social Security Act, which requires that the payment rates for ambulatory surgical center services be reviewed and updated annually, and responds to public comments we received concerning the ambulatory surgical center payment rate update notice published on February 8, 1990 (55 FR 4577).     

Medicare program; schedule of limits on home health agency costs per visit--HCFA. Notice with comment period

This notice with comment period sets forth a revised schedule of limits on home health agency costs that may be paid under the Medicare program for cost reporting periods beginning on or after July 1, 1993. These limits replace the per-visit limits that were set forth in our July 8, 1993 notice with comment period (58 FR 36748). This notice also provides, in accordance with the provisions of the Omnibus Budget Reconciliation Act of 1993 (OBRA '93), that there will be no changes in the home health agency (HHA) cost limits for cost reporting periods beginning on or after July 1, 1994, and before July 1, 1996. In addition, this notice responds to public comments on the July 8, 1993 notice with comment period, which originally set forth the HHA cost limits for cost reporting periods beginning on or after July 1, 1993, and on the January 6, 1994 notice with comment period (59 FR 760), which announced the elimination of the hospital based add-on effective for cost reporting periods beginning on or after October 1, 1993.     

Medicare program; prospective payment system for hospital outpatient services; extension of comment period--HCFA. Notice of extension of comment period for proposed rule

This notice extends the comment period for a proposed rule published in the Federal Register on September 8, 1998, (63 FR 47552). In that rule, as required by sections 4521, 4522, and 4523 of the Balanced Budget Act of 1997, we proposed to eliminate the formula-driven overpayment for certain outpatient hospital services, extend reductions in payment for costs of hospital outpatient services, and establish in regulations a prospective payment system for hospital outpatient services (and for Medicare Part B services furnished to inpatients who have no Part A coverage.) The comment period is extended for 60 days.     

Medicare and Medicaid programs; announcement of additional application from hospital requesting waiver for organ procurement service area--HCFA. Notice with comment period

This notice announces an additional application that HCFA has received from a hospital requesting waiver from dealing with its designated organ procurement organization (OPO) in accordance with section 1138(a)(2) of the Act. This notice requests comments from OPOs and the general public for our consideration in determining whether such a waiver should be granted.     

Medicare program; update of ambulatory surgical center list of covered procedures. Interim final rule with comment period

This interim final rule with comment period revises the list of procedures that are covered when furnished in an ambulatory surgery center (ASC) in accordance with section 1833(i)(1) of the Social Security Act. We published our proposed deletions and additions in the Federal Register on November 26, 2004. In this interim final rule, we respond to public comments and make final additions to and deletions from the current list of Medicare approved ambulatory surgical center (ASC) procedures.     

Medicaid program; allocation of enhanced federal matching funds for increased administrative costs resulting from welfare reform--HCFA. Notice with comment period

This notice with comment period announces the methodology used to determine the allocation, among the States and certain Territories, of a $500 million fund to assist them with the additional expenses attributable to eligibility determinations incurred as a result of the provisions of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996, which decouples Medicaid eligibility from receipt of cash assistance for families and children. Also, it announces the actual allocation amount for each State and Territory. The special fund is available for matching a State's or Territory's allowable administrative expenditures incurred only during Federal fiscal years 1997 through 2000, and only during the first 12 calendar quarters in which the State's Temporary Assistance to Needy Families program, which replaced the Aid to Families with Dependent Children program, is in effect after August 21, 1996.